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Patient Blood Management in Patients Scheduled for Cardiac Surgery

Patient Blood Management in Cardiac Surgical Patients: the ICARUS-2 Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06637137
Acronym
ICARUS-2
Enrollment
464
Registered
2024-10-15
Start date
2025-02-24
Completion date
2027-02-28
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Anemia, Iron-Deficiency, Blood Loss, Surgical, Cardiac Surgical Patients, Iron Deficiency Anemia (IDA), Iron Deficiency Anemia Treatment

Keywords

iron, anemia, cardiac surgery, patient blood management

Brief summary

The ICARUS 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective cardiac surgery in order to correct any states of hypoferritinemia (low iron in the blood) to promote recovery from blood losses related to cardiac surgery. This objective is strongly encouraged by the good use of blood programs currently in force at our foundation. In particular, the research presented here intends to demonstrate a reduction in the number of intra- and post-operative transfusions.

Detailed description

A significant percentage of patients schduled for cardiac surgery have an absolute or relative iron deficiency (ID) with or without anemia. Preoperative outpatient treatment of anemia and iron deficiency is one of the pillars of patient blood management (PBM). Data collected at our institution show that 35% of patients undergoing cardiac surgery at the Foundation receive 2 or more units of concentrated red blood cells at surgery or in the following 7 days. A recently published ambispective study (ICARUS) demonstrated that intravenous iron supplementation, even in the immediate pre-operative period (i.e 1 or 2 days), reduces the number of post-operative transfusions and the length of hospital stay. Similar results were recently obtained by other authors in a randomized study. Assuming the correction of ID at an earlier stage, the haematological outcome could be significantly better, with a reduction in the percentage of patients transfused and in the average transfusion requirement, increase in haemoglobin levels at discharge, improvement in clinical conditions and possible further reduction of the length of stay. All this could translate into a further reduction in costs related to the intervention. The study is observational and involves the early application of the PBM program based on good clinical practice which includes the correction of absolute or relative ID. This deficiency will be treated at least 2 weeks before the planned cardiac surgery: the patient will receive an i.v. of iron in the clinic, in accordance with the indications, doses and route of administration for which the use of the drug is approved and the drug distributed on the market. At the same time as iron administration, vitamin supplementation will be prescribed (Vitamin B12 1 mg total subcutaneously) and oral folic acid (5 mg/day).

Interventions

DRUGIron

Patients who present a state of hypoferritinemia or a state of reduced transferrin saturation will undergo administration of i.v iron at least 2 weeks before scheduled cardiac surgery, plus acid folic and B vitamin co-administration.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- all adult patients scheduled for elective cardiac surgery

Exclusion criteria

* pregnancy * dyalisis * patient's refusal

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients receiving RBC transfusion within post-operative day 7within post operative day 7number of RBC units transfused from the operating room till post operative day 7

Secondary

MeasureTime frameDescription
cost measured in euros for the IDA treatment and blood product consumptionfrom enrollment to 1 week after surgeryWe will assess if ID screening and iron replacement is cost-effective, considering the costs, expressed in euros, of the treatment with ferric carboxymaltose, folic acid and B12 vitamin, the pRBC consumption and hospitalization (either in ICU or in the regular ward).
Hb values at last postoperative control within 7 days from surgerywithin post operative day 7Hb values at last postoperative control within 7 days from surgery
ICU lenght of staythrough study completion, an average of 2 yearlenght of stay in ICU
Number of allogenic blood products administeredwithin the first 7 days post operativeNumber of allogenic blood products administered (i.e fresh frozen plasma or platelet units).
mortalityfrom surgery within post operative day 7patients died within the first 7 days after surgery
Hospital Lenght of Staythrough study completion, an average of 2 yearThe number of days spent in the hospital

Countries

Italy

Contacts

CONTACTfilippo Corsi, MD
filippo.corsi@policlinicogemelli.it+390630151
CONTACTLuciana Teofili, PhD, MD
+390630151
STUDY_DIRECTORluciana Teofili, Phd

Fondazione Policlinico Gemelli, IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026